Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy(immunogenicity) of gc3111 in healthy adults

Conditions: Tetanus; Diphtheria; Whooping Cough

Summary: the purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of gc3111 versus boostrix® vaccine among healthy adults in 19-64 years of age.

to evaluate immunogenicity of gc3111 as tetanus, diphtheria and acellular pertussis (tdap) vaccine in healthy adults. to evaluate safety of gc3111 in healthy adults.

Eligibility criteria:
inclusion criteria: 1. healthy adults aged above 19 and under 64 at the time of screening 2. subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug 3. subject who provided informed consent and assent forms exclusion criteria: 1. subject who received vaccine within 4 weeks prior to receiving study vaccine 2. subject who received tdap vaccine prior to receiving study vaccine 3. subject with chronic cough history within 12 weeks before receiving study vaccine 4. subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence 5. subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine 6. subject with any condition that, in the opinion of the investigator, might interfere with the ability to comply with trial procedures
fifty two week extension trial of org 50081 (esmirtazapine) in the treatment of insomnia (p05708)

Conditions: Insomnia

Summary: this trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of org 50081 (esmirtazapine) in participants who completed protocol 176001 (p05706) (nct00482612) or 176002 (p05707) (nct00506389). participants who have completed protocol p05706 or p05707, and are willing to continue treatment with esmirtazapine, can participate in protocol 176004 (p05708) after signing informed consent.


Eligibility criteria:
inclusion criteria: * sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations; * completed protocol p05706 or p05707; * have safety and efficacy assessments conducted per protocol p05706 or p05707. exclusion criteria: * clinically relevant electrocardiogram (ecg) abnormalities as judged by the investigator; * clinically relevant abnormal laboratory values as judged by the investigator; * any adverse event deemed relevant for exclusion in protocol p05708 as judged by the investigator or, * were significantly non compliant with protocol criteria and procedures of protocol p05706 or p05707, as judged by the investigator.

Keywords: fifty two weeks open label extension
the effect of nocturnal haemodialysis on arterial stiffness

Conditions: End Stage Renal Disease; Arterial Stiffness

Summary: arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium which reduce blood vessel compliance. although there is growing evidence that increased arterial stiffness is associated with chronic kidney disease (ckd), its pathogenesis is unclear. pulse wave velocity (pwv) and augmentation index (aix) provide tools for estimating arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. the aims of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical and biochemical parameters.


Eligibility criteria:
inclusion criteria: * adult dialysis patients * able to perform home nocturnal haemodialysis exclusion criteria: * age \ 80 years * any patient who is anticipating a live renal transplantation in forthcoming 12 months

Keywords: arterial stiffness artery aortic pulse wave velocity pulse wave analysis augmentation index end stage renal disease nocturnal hemodialysis extended hours of hemodialysis cardiovascular hemodialysis
the grow to recovery train-the-trainer program

Conditions: Mental Disorders; Recovery

Summary: recovery-oriented services are becoming popular in the mental health field. however, recovery-oriented services are still in the beginning stages in taiwan. many professionals do not know how to implement recovery-oriented services. more effort should be made to improve mental health services in taiwan. hence, the aim of this study is to examine the effectiveness of the grow to recovery train-the-trainer program.

the study will verify the effectiveness of the train-the-trainer program with the cluster randomized controlled trial design. the resesarchers will recruit 10 psychiatric rehabilitation organizations, including 80 mental health professionals and 160 people with mental illness. the professionals of the intervention group will receive a online training and then conduct a 5-month recovery group. the organization-level and service user assessments will be collected to examine the overall outcomes.

Eligibility criteria:
inclusion criteria: professionals: 1. working in the community psychiatric rehabilitation organizations 2. being willing to participate in the study people with mental illness 1. having a diagnosis of mental illness 2. living in the community 3. being age 20 yr or older 4. receiving services from the collaborating organizations 5. filling out the scales independently 6. being able to participate in a recovery group and follow the group rules exclusion criteria: * attending another recovery-related group

Keywords: recovery program
impact of mobile phone application use on adult bls

Conditions: Out-Of-Hospital Cardiac Arrest; Mobile Phone Use; Stress; Knowledge, Attitudes, Practice

Summary: the aim of the study is to investigate whether a serious smartphone game (called mobi-cpr game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills.

the trial design will be randomized, controlled, cross-over study. data will be collected between march and may 2023 at the faculty of health science, university of maribor. the consentience of nursing students will be collected. the faculty of health science, university of maribor already give permission for conducting this study. the goal will be to have around 100 nursing students in the study. in the study a serious smartphone game called mobi-cpr will be used. the mobi-cpr game will be available at https://mobicpr.si/. the mobi-cpr game will be install on the smartphone and will be used at home by nursing students with a goal to obtain adult basic life support knowledge and skills. before each nursing student will get mobi-cpr game for home usage we will 1) measure acute stress, and 2) assess adult basic life support knowledge and skills. for measuring acute stress the empatica e4 watch will be used. measuring will be perform in a quiet room without disruptions. when measuring acute stress each nursing student will be coloring the mandalas circles. level of acute stress measure by empatica e4 watch (1-5 is non stress area, and 6-10 is stress area). for the knowledge part the online modified questionnaire (available in: https://www.1ka.si/d/en) the multiple choice questions will be used, and for the skills part the resusci anne qcpr qcpr manikin and defibtech trainer aed will be used. each nursing student will be given the scenarios to read before the start of the assistance to the victim of a sudden cardiac arrest. the investigators will use a modified checklist to assess students' performance in adult basic life support.

Eligibility criteria:
inclusion criteria: * nursing students over eighteen years old * without training in adult basic life support or within the past six mounts * physically able to perform cpr * willingness to perform rescue breathing on a manikin * a completed and signed consent form exclusion criteria: * nursing student younger than 18 years old * undergone training on adult basic life support within the past six mounts * physically not able to perform cpr * do not want to perform rescue breathing on a manikin * do not want to participate

Keywords: basic life support adult mobile learning stress knowledge skills retention home
patient preference study: standard of care versus once-daily trientine tetrahydrochloride

Conditions: Wilson's Disease

Summary: decentralized study to assess patient reported treatment satisfaction comparing their current standard-of-care wilson's disease (wd) treatment with a new once-daily trientine (teta) 4hcl formulation.

this is a single arm study where patients on standard of care maintenance therapy with a prescribed approved wilson's disease therapy administered at least twice daily will be screened for eligibility by the clinical research site either following referral from a participant identification centre (pic) or following advertisements. an initial screening patient reported outcome (pro) assessment including the treatment satisfaction questionnaire for medication-9 (tsqm-9) and morisky medication adherence scale-8 (mmas-8) will also be collected. patients who meet all the study entry criteria will be switched to a new teta 4hcl formulation for 28 days and will be monitored using patient reported outcomes and specific posology questions held within a patient questionnaire pack and blood investigations. during this treatment phase (between day 14 and day 28 of dosing), each participant will be interviewed to collect qualitative data on disease and therapy. patients will then be returned to their standard of care treatment and followed for a further 28 days continuing to be assessed using patient reported outcomes and repeat blood investigations. the safety period will be finalised with an end of study assessment.

Eligibility criteria:
inclusion criteria: 1. willing and able to give informed consent for participation in the study. 2. proficient and fluent in english language speaker, writer and reader. 3. patients of any gender, aged 18 years or older as of signing the informed consent form (icf). 4. patients on current soc wd maintenance treatment prescribed twice daily (or more frequently) and dose has been unchanged for at least 3-months. 5. women of childbearing potential and sexually active males must agree to adhere to a contraceptive method. exclusion criteria: 1. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the collection or interpretation of the study results. 2. patients with severe anaemia (e.g., haemoglobin \<10 g/dl). 3. female participants who are pregnant (including a positive pregnancy test at screening and on day-1) or breastfeeding. 4. any contraindications as described in the current investigator brochure for teta 4hcl. 5. subject receiving total daily dose of chelator as soc greater or equal to 1200mg (trientine base or d-penicillamine). 6. in the opinion of the investigator, the patient is likely to be a non-attender or uncooperative for routine clinical visits during the study.
tavi protocol - paravertebral block study

Conditions: Aortic Valve Replacement; Aortic Stenosis

Summary: trans-apical aortic valve replacement is a new treatment for severe aortic stenosis. it is offered to elderly patients with medical problems that would markedly increase the risk of conventional cardiac surgery. the rate of delirium (acute confusional state) after surgery in these patients may exceed 50%. estimated hospital costs associated with delirium at toronto general hospital last year exceeded $1-million cad. pain after surgery and the use of opioids (morphine type of pain-relief drugs) are known to increase the risk of delirium. the investigators plan to minimize the use of opioids and improve pain management by replacing the standard intravenous opioid-based pain management with the paravertebral nerve block using only the local anesthetic. these two management strategies will be compared with respect to the rate of delirium, duration of hospital stay, and the overall costs. hypothesis: paravertebral analgesia with la decreases the incidence of delirium after trans-apical avr when compared to standard systemic opioid-based analgesia.

a prospective, randomized, controlled, multicentre study (toronto general hospital and sunnybrook health science centre, toronto, canada.) the investigators are planning to replace the standard intravenous opioid analgesia with a continuous paravertebral block using local anesthetic after trans-apical aortic valve replacement. anesthesia management will be standardized to minimize any impact that anesthetic type may have on neurological outcomes. metrics to evaluate outcomes: assessment of delirium will be performed utilizing the cam-icu preoperatively (baseline) and postoperatively every 12 hours or as needed according to the patient's condition during the first 7 postoperative days or until discharge. the cam recognizes both, hyperactive and hypoactive, forms of delirium. it includes four-step algorithm and assesses 1) an acute onset of changes or fluctuations in the course of mental status, 2) inattention, 3) disorganized thinking and 4) an altered level of consciousness. the patient is determined to be delirious (cam positive) if he/she manifests both features 1 and 2, plus either feature 3 or 4. primary screening for delirium will be performed by the nursing staff. diagnose of delirium will be confirmed by the psychiatry consult. assessment of sedation and pain: standardized according to institutional guidelines. cost calculations: the total cost (summation of direct-variable, direct-fixed, and overhead costs) for each patient will be determined for both study groups.

Eligibility criteria:
inclusion criteria: * consenting subjects who are scheduled to undergo the tavi surgical procedure exclusion criteria: * patients with symptomatic cerebrovascular disease, * history of delirium and schizophrenia

Keywords: delirium pvb pca opioid aortic valve replacement
safety and efficacy of adalimumab (humira) for hidradenitis suppurativa (hs) peri-surgically

Conditions: Hidradenitis Suppurativa (HS)

Summary: the objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe hidradenitis suppurativa (hs) who were surgical candidates.

this was an interventional, randomized, double-blind (db), placebo-controlled study. the study duration included a 30-day screening period, an initial 12-week db treatment pre-surgery period (period a), a 2-week peri-operative period with continuation of weekly db study drug administration (period b), and a subsequent 10-week db treatment post-operative period (period c). randomization (in a 1:1 ratio) in period a was stratified by baseline hurley stage (ii versus iii) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). the projected size of the surgical excision established by the designated surgeon during the screening period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. in period b, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during week 13. surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. no study drug was administered at week 24, the final study visit. participants were able to begin commercial product (as prescribed by the participants's physician) after all week 24 procedures were completed.

Eligibility criteria:
inclusion criteria: * participant must have skin lesions that are diagnostic of hidradenitis suppurativa (hs) for at least 1 year (365 days) prior to the baseline visit * participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') hs lesions; plus * either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and * with at least one of the other affected hs regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as hurley stage ii or iii * participant must have a total abscess and inflammatory nodule (an) count of greater than or equal to 3 at the baseline visit within the hs non-surgical sites * the hs surgical site must contain at least one active hs lesion * the hs surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon exclusion criteria: * participant has a draining fistula count of greater than 20 at the baseline visit * participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site * participant requires surgical management prior to week 13 * participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant

Keywords: hidradenitis suppurativa axilla inguinal region hurley stage i, ii, or iii adalimumab secondary intention abcess and inflammatory nodule (an) count
investigate the effect of the creon2000a on asthma control in children with mild to moderate persistent asthma

Conditions: Asthma

Summary: this is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double blind study with an allocation ratio of 1:1. the study population is children between the ages 6 to 17 years, with mild to moderate persistent asthma. the purpose of the study is to determine whether the creon2000a, an environmental control device, will decrease asthma severity, as measured by the composite asthma severity index (casi), in children with mild to moderate persistent allergic asthma over a twelve month period.

the pilot study (protocol #pa-01-052; health effects of creon2000 in asthmatic children. ib id# gi 1001) offered preliminary evidence that the creon2000a system may be beneficial in asthma. this study is a follow-up, using children, aged 6 to 17 with mild to moderate persistent asthma, as the subjects of the study. children are usually treated with fewer controller medications and have fewer confounding co-morbidities making it more likely to detect a therapeutic benefit from an environmental intervention. the study will involve 4 study site visits, 2 home visits, and 7 phone calls. adjustment of asthma therapy by the site clinician will occur at baseline (visit 1) and at each follow-up office visit after visit 1 using a modified algorithm based on the national asthma education and prevention program expert panel report 3 (naepp epr3) guidelines. enrollment will be over 18 months. the study duration for each subject will be 12 months.

Eligibility criteria:
inclusion criteria 1. males and females ages 6.0 to 17.0 years. 2. subjects with a physician diagnosis of mild or moderate persistent asthma. 3. fev1 ≥ 60% predicted with ≥ 12% improvement after bronchodilator therapy. 4. must have evidence of; 1) serum specific ige (immunocap) ≥ .35 or 2) a positive skin prick test to one or more common indoor allergens including standardized house dust mite, cat, dog, cockroach, mouse in the past. exclusion criteria 1. current smokers 2. passive exposure to environmental tobacco smoke at home or active fireplaces and other sources of air particulates (wood burning stoves, kerosene heaters) at home. 3. diagnosed by a physician with a chronic lung disease other than asthma. 4. upper or lower respiratory infection within four weeks prior to enrollment. 5. known to have any other chronic illness (besides asthma) that is not well controlled at the time of screening (visit 1). 6. history of a life threatening asthma attack requiring cardiopulmonary support, intubation with ventilatory support, hospitalization in an intensive care unit or hospitalization for asthma within 6 months preceding study screening (visit 1). 7. participation in another investigational drug/device study within the past 3 months (not including chart or observational studies)

Keywords: asthma environment
the degree of knowledge and attitude of egyptian physicians regarding emergency treatment of traumatic dental injuries

Conditions: Traumatic Dental Injuries

Summary: this study intends to evaluate physicians' fundamental knowledge and attitude regarding the management of tdis in egypt. a convenience sample of physicians will be enrolled in this cross-sectional study, and they will be asked to complete a validated questionnaire. the questionnaire includes demographic questions, two case scenarios involving crown fractures and the avulsion of permanent teeth, and self-evaluation questions.

several epidemiological studies continue to show significant levels of dental trauma in many countries. in industrialized countries, about one in five children experience a traumatic dental injury (tdi) to permanent teeth before leaving school. primary care providers (e.g., family physicians, pediatricians, emergency medicine physicians and nurses) can play an important role in offering primary care following dentofacial trauma, especially for rural populations with limited access to dentists. several global studies indicate that physicians and even pediatricians lacked the emergency management knowledge to deal with traumatic dental injuries (tdis). emphasizing the fact that medical students are not well educated or trained to manage tdis. to the best of our knowledge, no study has been conducted in egypt to investigate physicians' knowledge and attitudes addressing traumatic dental injury.

Eligibility criteria:
inclusion criteria: physicians who accept to participate. exclusion criteria: physicians who refuse to participate.

Keywords: traumatic dental injuries awareness knowledge attitude
effects of isometric muscle training on shoulder pain, function and performance in bowlers

Conditions: Shoulder Pain

Summary: goal of this clinical trial is to determine whether isometric muscle training decrease pain improve function and enhance performance. does isometric exercise improve pain function and performance in bowlers? researcher will compare the isometric muscle training with traditional therapy to examine that isometric exercise work on pain function and performance. participants will receive isometric exercises for three days in week and will be followed up after two weeks total four weeks of trial(experimental group). participants will receive traditional physical therapy treatment three days of week and followed up after two weeks total four weeks of trail (contril group)

this research is critical for addressing a common health concern and providing evidence-based recommendations for a potentially effective and accessible intervention that can significantly enhance the quality of life and performance of individuals dealing with shoulder pain. thesis will benefit the bowlers by increasing their performance by enhancing accuracy, speed and consistency and over all shoulder health. because shoulder discomfort is so common and has such a detrimental influence on everyday activities and performance, research on how isometric muscle training affects shoulder pain, function, and performance is crucial. in a variety of settings, isometric training has demonstrated promise in enhancing musculoskeletal function and pain management; however, its precise influence on shoulder-related problems is yet unknown.

Eligibility criteria:
inclusion criteria: * active male bowlers * age 18 - 30 * pain that affects performance. any level of pain that significantly affects a bowler's performance, accuracy, or consistency. * pain with psychological impact. pain that causes emotional distress, anxiety, or frustration. * rotator cuff pain. * weekly 6 to 8 hour training exclusion criteria: * other than bowlers

Keywords: isometric shoulder pain bowlers performance